T-Control® Safety for Cytostatics Management
ConditionNon-muscle-invasive Bladder Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRethink Medical SL
About this trial
The goal of this pilot clinical trial is to know if this study is feasable in terms of design, recruitment and interventions, as well as gather preliminary data to determine if the T-Control® catheter is safer than the conventional Foley-type catheter during intravesical therapy with oncological patients. It will also learn about the usability of T-Control®. The main questions it aims to answer are:
* Does T-Control® lower the rate of spillages occurred during intravesical treatments? * Is T-Control® a better device in terms of usability during intravesical treatments?
Researchers will compare T-Control® catheter to a conventional Foley-type catheter (Folysil® Silicone catheter, Coloplast) to see if T-Control® reduce the rate of accidental spillages.
Participants will:
* Undergo intravesical therapy with the 2 devices used in the study (in two seuqencial cycles of intravesical treatment): T-Control® catheter (experimental intervention) or Folysil® silicone catheter (control intervention). * At the end of the procedure (1-2 hours), the catheter will be removed or changed. During the first visit, patients will be catheterised with the catheter for the randomly assigned intervention, while in the subsequent visit they will be catheterised with the alternate catheter. * Healthcare professionals involved in the procedure will take note of spillages and others adverse events occurred during the intravesical instillation. * At the end of the study, healthcare proffesionals will evaluate the usability perceived of both devices used for intravesical treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men or women aged ≥18 years.
Patients with bladder cancer who require intravesical treatments with chemotherapy or immunotherapy.
Patients requiring recurrent intravesical instillations for their treatment.
Signed consent agreement.
Disqualifiers
Patients with difficult catheterisation who require a urologist to perform the catheter insertion.
Inability to read and understand Portuguese or english.
Trial design
Design model
Crossover
Treatments tested in this trial
T-Control® (experimental)
DevicePatients will receive intravesical therapy (1-2 hours) through T-Control®, a new Foley-type silicone catheter with an integrated fluid-control valve into the catheter's distal end, which has three positions.
Folysil® (control)
DevicePatients will receive intravesical therapy (1-2 hours) through Folysil® Silicone catheter (Coloplast), the usual clinical practice in the participating center.
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: T-Control®Experimental treatment 1 intervention
Group B: Folysil®Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of accidental spillages
The number of spillages with cytostatics, body fluids or other non-hazardous spillages divided by the number of interventions (intravesical therapy procedures)
Time frame
Intravesical therapy procedure (1-2 hours)Secondary outcomes
1
General device-usability
The degree of usability perceived by the health professionals involved in the intravesical procedure will be evaluated through the validated USE Questionnaire on more general usability for medical devices.
Time frame
Intravesical therapy procedure (1-2 hours)2
Specific device-usability
The degree of usability perceived by the health professionals involved in the intravesical procedure will be evaluated through an ad hoc questionnaire on usability during intravesical therapy.
Time frame
Intravesical therapy procedure (1-2 hours)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: